NCT04451096

Probiotics-prebiotic Fiber Therapy in Parkinson's Disease Patients With Constipation

Completed Phase 3 Last updated 30 June 2020

What this trial tests

Phase 3 trial testing Probiotics with prebiotic in Parkinson Disease in 48 participants. Completed in 28 February 2019.

Timeline

6 October 2018

Primary endpoint
28 February 2019

28 February 2019

Quick facts

Lead sponsor	National University of Malaysia
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	48
Start date	6 October 2018
Primary completion	28 February 2019
Estimated completion	28 February 2019
Sites	1 location across Malaysia

Drugs / interventions tested

• Probiotics with prebiotic
• Placebo

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →
• Constipation — all drugs for Constipation →

Sponsor

National University of Malaysia

Who can join

18 and older, any sex, with Parkinson Disease or Constipation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A double blinded randomised placebo controlled trial to evaluate the efficacy of probiotics on constipation symptoms and whole gut transit time in patients with Parkinson's disease.PD patients with constipation were randomized to receive a multi-strain probiotic (Lactobacillus spp and Bifidobacterium spp at 30 X 109 CFU) with fructo-oligosaccaride (FOS) or placebo (fermented milk) twice daily for 8 weeks. Primary outcomes include changes in the presence of constipation symptoms using 9 items of Garrigues Questionnaire (GQ), which included an item on bowel opening frequency. Secondary and exploratory outcomes include whole gut transit time (WGTT), quality of life (PDQ39-SI), motor (MDS-UPDRS) and non-motor symptoms (NMSS).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Microbiota-gut-brain axis and its therapeutic applications in neurodegenerative diseases.
   Loh JS, Mak WQ, Tan LKS, Ng CX, et al · · 2024 · cited 631× · PMID 38360862 · DOI 10.1038/s41392-024-01743-1
2. Multi-strain probiotics (Hexbio) containing MCP BCMC strains improved constipation and gut motility in Parkinson's disease: A randomised controlled trial.
   Ibrahim A, Ali RAR, Manaf MRA, Ahmad N, et al · · 2020 · cited 123× · PMID 33382780 · DOI 10.1371/journal.pone.0244680
3. Gut microbiome and Parkinson's disease: Perspective on pathogenesis and treatment.
   Salim S, Ahmad F, Banu A, Mohammad F. · · 2023 · cited 60× · PMID 36332796 · DOI 10.1016/j.jare.2022.10.013
4. New Pieces for an Old Puzzle: Approaching Parkinson's Disease from Translatable Animal Models, Gut Microbiota Modulation, and Lipidomics.
   Ortega Moreno L, Bagues A, Martínez V, Abalo R. · · 2023 · cited 8× · PMID 37375679 · DOI 10.3390/nu15122775
5. Probiotics as Potential Treatments for Neurodegenerative Diseases: a Review of the Evidence from <i>in vivo</i> to Clinical Trial.
   Kim JH, Choi Y, Lee S, Oh MS. · · 2025 · cited 7× · PMID 39676295 · DOI 10.4062/biomolther.2024.215
6. "Janus-Faced" α-Synuclein: Role in Parkinson's Disease.
   Ray B, Mahalakshmi AM, Tuladhar S, Bhat A, et al · · 2021 · cited 7× · PMID 34124057 · DOI 10.3389/fcell.2021.673395
7. Management and Prevention of Neurodegenerative Disorders: Can Antioxidant-Rich Dietary Interventions Help?
   Nagpal D, Nema S, Nagpal S, Pandey MM, et al · · 2025 · cited 2× · PMID 41008984 · DOI 10.3390/antiox14091078
8. Nanotherapeutic Interventions for Parkinson's Disease: Modulating Pathogenic Mechanisms and Overcoming Therapeutic Obstacles.
   Yin X, Wang C, Lin W, Huang S, et al · · 2026 · PMID 41907367 · DOI 10.2147/ijn.s570452